Beta-hydroxybutyrate to boost immunotherapy in multiple myeloma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized interventional trial assigns adults with multiple myeloma who are planned for BCMA-targeted CAR‑T or a BCMA-directed bispecific antibody to one of four active interventions or to standard nutritional care. Active arms include a strict ketogenic diet (<10% calories from carbohydrates) or oral ketone monoester (deltaG®) given three times daily at either a low (40.5 g/day) or high (75 g/day) dose. The study will monitor blood beta-hydroxybutyrate levels, safety and tolerability, and measures of immunotherapy response to see if higher BHB levels correlate with improved immune activity and clinical outcomes. Key exclusions include active infections, prior immunoeffector therapy, significant recent weight loss, very high tumor burden with tumor lysis risk, and inability to exclude pregnancy.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Multiple Myeloma with indication for CAR-T cell therapy with Ciltacabtagene autoleucel (target antigen: BCMA) or a BCMA-directed bispecific antibody (e.g., Teclistamab, Elranatamab, Linvoseltamab).
* Age ≥18 years on the day the informed consent is signed.

Exclusion Criteria:

* Active infection requiring systemic therapy.
* Known history of infection with Human Immunodeficiency Virus (HIV) or Hepatitis.
* Significant short-term weight loss (\>10% within the last 6 weeks).
* ECOG Performance Status ≥2.
* Prior immunoeffector cell therapy (CAR-T cell therapy or bispecific antibodies).
* Active immunosuppression due to another condition (e.g., autoimmune disease, second malignancy).
* Very high tumor burden with high risk for tumor lysis syndrome, as determined by myeloma-specific markers or markedly elevated LDH (per the treating myeloma team).
* Women of childbearing potential in whom pregnancy cannot be reliably excluded prior to study entry.

Where it's running

• University Medical Center Hamburg-Eppendorf
  Hamburg, Free and Hanseatic City of Hamburg, Germany Recruiting

Study contacts

• Principal investigator: Joseph Tintelnot, MD — Universitätsklinikum Hamburg-Eppendorf
• Study coordinator: Jan Weller, MD
• Email: j.weller@uke.de
• Phone: 0049 40 7410 0

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.